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519
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489
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403
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Manufacturers
US
Organon, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Organon, Inc. - FDA 510(k) Cleared Devices
41 submissions
·
41 cleared
·
Since 1977
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Organon, Inc.
Toxicology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 10, 1980
OREIA-Q-DIG
K802358
·
KXT
Toxicology
·
14d
Cleared
Apr 10, 1979
OREIA - DIGOXIN
K790521
·
KXT
Toxicology
·
25d
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41
Chemistry
23
Immunology
8
Microbiology
3
General Hospital
3
Hematology
2
Toxicology
2